Chronic Postoperative PainNCT06281431
A Comparative Effect of Echogenic Needle for Nerve Block on Acute and Chronic Postoperative Pain
A study testing Echogenic nerve block needle and Non-echogenic nerve block needle in people with Chronic Postoperative Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
Surgical pain is a common complication after surgery, affecting patient recovery and treatment quality. >20% of patients suffer from chronic postoperative pain. China has >70 million surgeries yearly. Nerve block manages postoperative pain, with developing nerve block needles now used in clinics. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Postoperative Pain
- What is being tested?
- Echogenic nerve block needle and Non-echogenic nerve block needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age is above 18 years old and below 70 years old.
- patients whose surgical sites were in the chest, abdomen, upper limbs or lower limbs, including lobectomy, cholecystectomy, gastrointestinal resection, hysterectomy and other elective operations.
- This operation was the first operation during the hospitalization.
- Consent to participate in this study and sign an informed consent form.
Who cannot join
- Patients with a history of alcohol or drug addiction.
- Patients with disturbance of consciousness before operation.
- Other conditions considered by the attending physician or researcher to be inappropriate for the study;
- History of chronic pain.
- Abnormal coagulation function.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
He Huang
Chongqing, Chongqing Municipality, 4000000
He Huang, ph.D, 13708385559, huanghe@cqmu.edu.cn
About this study
Surgical pain is a common complication after surgery, affecting patient recovery and treatment quality. >20% of patients suffer from chronic postoperative pain. China has >70 million surgeries yearly. Nerve block manages postoperative pain, with developing nerve block needles now used in clinics. Developed needles may have better pain management effects than non-developed ones, but their effect on reducing chronic pain remains unclear. This study aims to explore the effect of developed nerve block needles on postoperative pain and compare them to non-developed needles, providing new ideas and methods for pain management.
Read the detailed description
Surgical pain is one of the common complications after surgery, which seriously affects the recovery and treatment quality of patients. More than 20% of patients will suffer from postoperative chronic pain. According to the data of the National Bureau of Statistics, there are more than 70 million surgeries in China every year. Nerve block is one of the most commonly used methods for postoperative pain management in clinical practice. In recent years, the developing nerve block needle has gradually begun to be used in clinical practice. Compared with the ordinary non-developing nerve block needle, it may have a better effect on pain management after surgery, but whether it has a reduction effect on chronic pain after surgery is still unknown. The purpose of this study is to explore the effect of developing nerve block needle on postoperative pain, and to compare the difference between it and the common non-developing nerve block needle, so as to provide new ideas and methods for postoperative pain management.
- Conditions
- Chronic Postoperative Pain
- Being tested
- Echogenic nerve block needle, Non-echogenic nerve block needle
- Keywords
- Visualized nerve block needle, Acute pain, Chronic pain
- Medical subject headings
- Pain, Postoperative, Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echogenic nerve block needleProcedure or surgery
A 22G 8-cm echogenic nerve block needle (LEAPMED, CHINA) is selected for the procedure, administered under ultrasound guidance. Subsequently, a volume of 20 ml 0.375% ropivacaine is injected at the needle's tip for analgesic effect. The spread of the medication will be assessed through short- and long-axis imaging perspectives. Following this, evaluations are conducted to assess acute postoperative pain as well as chronic postoperative pain. Parameters such as the duration of nerve blockade, the incidence of punctures, and any associated complications are all meticulously appraised.
Non-echogenic nerve block needleProcedure or surgery
A 22G 8-cm thin wall low bottom nerve block needle (KDL, CHINA) is selected for the procedure, administered under ultrasound guidance. Subsequently, a volume of 20 ml 0.375% ropivacaine is injected at the needle's tip for analgesic effect. The distribution of the medication will be assessed using short- and long-axis imaging perspectives. Following this, evaluations are conducted to assess acute postoperative pain as well as chronic postoperative pain. Parameters such as the duration of nerve blockade, the number of punctures, and any associated complications are all meticulously appraised.
| Study group | Role | What they receive |
|---|---|---|
| Echogenic nerve block needle | Experimental | Using a echogenic nerve block needle. Receives: Procedure: Echogenic nerve block needle |
| Non-echogenic nerve block needle | Other | Using a common nerve block needle. Receives: Procedure: Non-echogenic nerve block needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic postoperative pain
Incidence of Chronic pain assessment from 3 months after surgery
Measured: The third month after surgery.
Moderate to severe pain
Pain intensity (assessed by number rating scale, 0 represents no pain, 10 represents intolerable pain) more than 4
Measured: from end of surgery to 24 hours after surgery.
Secondary outcomes (5)
Acute postoperative pain
Pain intensity (assessed by number rating scale, 0 represents no pain, 10 represents intolerable pain) more than 4
Measured: From the ending of surgery to leaving the postanesthesia care unit, an average of 30 minutes
Acute postoperative pain
Pain intensity (assessed by number rating scale, 0 represents no pain, 10 represents intolerable pain) more than 4
Measured: From return to the ward to 12 hours after return to the ward
Acute postoperative pain
Pain intensity (assessed by number rating scale, 0 represents no pain, 10 represents intolerable pain) more than 4
Measured: From 12 hours after return to the ward to 24 hours after return to the ward
Puncture operation time
Time from needle insertion to needle extraction
Measured: From the ending of surgery to leaving the postanesthesia care unit, an average of 30 minutes
Number of needle passes
The number of times the needle is withdrawn more than 2 cm and resited
Measured: From the ending of surgery to leaving the postanesthesia care unit, an average of 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start12 Jun 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- He Huang, ph.D, Study chair, The Second Affiliated Hospital, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281431
- Sponsor's protocol ID
- CPSP
- Status last verified
- Jul 2024
- First submitted
- 14 Jan 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data for this study is available from the sponsor on reasonable request through email.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Effect of Echogenic Needle for Nerve Block on Acute and Chronic Postoperative Pain
- ClinicalTrials.gov ID
- NCT06281431
- Acronym / sponsor ID
- CPSP
- Conditions
- Chronic Postoperative Pain
- Keywords
- Visualized nerve block needle, Acute pain, Chronic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgical pain is a common complication after surgery, affecting patient recovery and treatment quality. >20% of patients suffer from chronic postoperative pain. China has >70 million surgeries yearly. Nerve block manages postoperative pain, with developing nerve block needles now used in clinics. Developed needles may have better pain management effects than non-developed ones, but their effect on reducing chronic pain remains unclear. This study aims to explore the effect of developed nerve block needles on postoperative pain and compare them to non-developed needles, providing new ideas and methods for pain management.
Detailed description
Surgical pain is one of the common complications after surgery, which seriously affects the recovery and treatment quality of patients. More than 20% of patients will suffer from postoperative chronic pain. According to the data of the National Bureau of Statistics, there are more than 70 million surgeries in China every year. Nerve block is one of the most commonly used methods for postoperative pain management in clinical practice. In recent years, the developing nerve block needle has gradually begun to be used in clinical practice. Compared with the ordinary non-developing nerve block needle, it may have a better effect on pain management after surgery, but whether it has a reduction effect on chronic pain after surgery is still unknown. The purpose of this study is to explore the effect of developing nerve block needle on postoperative pain, and to compare the difference between it and the common non-developing nerve block needle, so as to provide new ideas and methods for postoperative pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echogenic nerve block needle | Experimental | Procedure: Echogenic nerve block needleUsing a echogenic nerve block needle. |
| Non-echogenic nerve block needle | Other | Procedure: Non-echogenic nerve block needleUsing a common nerve block needle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The age is above 18 years old and below 70 years old.
- patients whose surgical sites were in the chest, abdomen, upper limbs or lower limbs, including lobectomy, cholecystectomy, gastrointestinal resection, hysterectomy and other elective operations.
- This operation was the first operation during the hospitalization.
- Consent to participate in this study and sign an informed consent form.
Key exclusion criteria (5 listed)
- Patients with a history of alcohol or drug addiction.
- Patients with disturbance of consciousness before operation.
- Other conditions considered by the attending physician or researcher to be inappropriate for the study;
- History of chronic pain.
- Abnormal coagulation function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echogenic nerve block needleA 22G 8-cm echogenic nerve block needle (LEAPMED, CHINA) is selected for the procedure, administered under ultrasound guidance. Subsequently, a volume of 20 ml 0.375% ropivacaine is injected at the needle's tip for analgesic effect. The spread of the medication will be assessed through short- and long-axis imaging perspectives. Following this, evaluations are conducted to assess acute postoperative pain as well as chronic postoperative pain. Parameters such as the duration of nerve blockade, the incidence of punctures, and any associated complications are all meticulously appraised. | Procedure or surgery | Echogenic nerve block needle |
| Non-echogenic nerve block needleA 22G 8-cm thin wall low bottom nerve block needle (KDL, CHINA) is selected for the procedure, administered under ultrasound guidance. Subsequently, a volume of 20 ml 0.375% ropivacaine is injected at the needle's tip for analgesic effect. The distribution of the medication will be assessed using short- and long-axis imaging perspectives. Following this, evaluations are conducted to assess acute postoperative pain as well as chronic postoperative pain. Parameters such as the duration of nerve blockade, the number of punctures, and any associated complications are all meticulously appraised. | Procedure or surgery | Non-echogenic nerve block needle |
Primary outcome
Chronic postoperative pain
Time frame: The third month after surgery.
Incidence of Chronic pain assessment from 3 months after surgery
Moderate to severe pain
Time frame: from end of surgery to 24 hours after surgery.
Pain intensity (assessed by number rating scale, 0 represents no pain, 10 represents intolerable pain) more than 4
5 secondary outcomes
Acute postoperative pain
Time frame: From the ending of surgery to leaving the postanesthesia care unit, an average of 30 minutes
Acute postoperative pain
Time frame: From return to the ward to 12 hours after return to the ward
Acute postoperative pain
Time frame: From 12 hours after return to the ward to 24 hours after return to the ward
Puncture operation time
Time frame: From the ending of surgery to leaving the postanesthesia care unit, an average of 30 minutes
Number of needle passes
Time frame: From the ending of surgery to leaving the postanesthesia care unit, an average of 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: Yes. The individual participant data for this study is available from the sponsor on reasonable request through email.
Related trials for Chronic Postoperative Pain
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Recruiting
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Chronic Post-surgical Pain, Chronic Post Operative Pain
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
He Huang, ph.D study chair
The Second Affiliated Hospital, Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Echogenic nerve block needle and Non-echogenic nerve block needle in people with Chronic Postoperative Pain, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He Huang, ph.D (13708385559, huanghe@cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic postoperative pain (time frame: The third month after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.